BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1000135 · Received February 19, 2008

    Report

    Report Number
    2134265-2008-00463
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A UNIT HAS NOT BEEN RETURNED FOR REVIEW, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT AT THIS TIME. THE ROOT CAUSE WILL BE DOCUMENTED AS AN ANTICIPATED PROCEDURAL COMPLICATION BECAUSE OF THE LIKELIHOOD THAT THE PATIENT ANATOMY CONTRIBUTED TO THE REPORTED COMPLAINT AND DUE TO THE LACK OF INFORMATION IMPLICATING A ROOT CAUSE RELATED TO THE DEVICE. A CAPA HAS BEEN INITIATED TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE COMPLETED AS THE BATCH NUMBER IS NOT KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THROMBOSIS OCCURRED. THE LESION WAS PRE-DILATED WITH A 2.0X15MM NON BSC BALLOON. THE PHYSICIAN PLACED A TAXUS EXPRESS2 2.5X20MM DRUG ELUTING STENT TO THE 75% STENOSED LESION LOCATED IN THE CALCIFIED, DISTAL LEFT CIRCUMFLEX (LCX) ARTERY. THE STENT WAS DEPLOYED AT 10 ATMS FOR 45 SECONDS, OVERLAPPING THE DISTAL PORTION OF A PREVIOUSLY PLACED NON BSC STENT. POST IVUS WAS PERFORMED AND CONFIRMED THE STENT WAS WELL POSITIONED AND WELL APPOSED. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS GOOD. TWELVE DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH CHEST PAIN AND ANGIOGRAPHY CONFIRMED A THROMBOSIS IN THE OVERLAPPED AREA OF THE PREVIOUSLY PLACED STENTS IN THE LCX. THE THROMBOSIS WAS TREATED WITH AN ASPIRATION CATHETER AND BALLOON DILATATION USING A 2.5X15MM NON BSC BALLOON. THE PATIENT WAS ON CILOSTAZOL AND ASPIRIN AT THE TIME OF THIS EVENT. CLOPIDOGREL AND ASPIRIN WERE PRESCRIBED POST PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS POST PROCEDURE IS NOTED AS "RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.5X20MM

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention CYPHER STENT| SPRINTER BALLOON